This invention relates to prosthetic heart valves, and more particularly to holders and other protection devices for prosthetic heart valve leaflets that may be useful during implantation in a patient.
There is increasing interest in artificial, prosthetic heart valves that use tissue material for the leaflets of the valve. Such valves tend to be less thrombogenic than mechanical prosthetic heart valves. This can reduce or eliminate the need for a patient who has received such prosthesis to take anti-coagulant medication on a long-term basis. Tissue-based heart valves may also have other advantages, such as quieter operation than mechanical valves. Because of the interest in such valves, improvements to them are greatly desired. Improved methods of making such valves are also sought. Efforts have also being made to find a more durable flexible leaflet material than tissue, such as polymer valves.
Despite the various improvements that have been made to prosthetic heart valves, conventional devices, systems, and methods suffer from some shortcomings. For example, in conventional heart valve replacement surgery, the leaflets of a replacement valve may be damaged during implantation. While a mechanical valve may be robust and not sensitive to scratches and/or scrapes from surgical instruments during implantation, the leaflets of polymer valves may be sensitive to such scratches. Valve durability and/or function may be compromised if sharp scratches are in stress sensitive locations, and may lead to tearing of the leaflet and limiting or impeding proper valve function.
There therefore is a need for further improvements to the devices, systems, and methods for prosthetic heart valve delivery and implantation. Among other advantages, the present invention may address one or more of these needs.